Multi-lumen endoscopic catheter

ABSTRACT

Multi-lumen catheters are intended for advancement through the accessory channel on endoscope into a body passage into the gastrointestinal system. The catheters have two or more independent lumens extending continuously to ports at the distal tip for injection of a contrast medium simultaneously with a guide wire for ERCP procedures and for passage of accessories such as visualization devices, polypectomy snares, cytology brushes, papillotomes and stone baskets for catheterization, diagnosis and treatment within the biliary tract. Use of balloons for maintaining a catheter in fixed position in the biliary tract and for dilatation is also disclosed. The catheters employed are extrusions of a resin comprised of nylon and PEBA. The catheters may also be extruded from polyurethane. Multi-lumen catheters having a reduced diameter distal tip portion on which a dilatation balloon is located are also disclosed. The reduced diameter distal tip portion may serve as a platform for support of a stent.

This application is a divisional of U.S. Ser. No. 08/189,317, filed Jan.31, 1994 now U.S. Pat. No. 5,599,299, which is a continuation-in-part ofU.S. Ser. No. 08/060,434, filed May 11, 1993 now U.S. Pat. No.5,397,302, which is a continuation-in-part of U.S. Ser. No. 07/880,842,filed May 11, 1992 now abandoned.

FIELD OF THE INVENTION

The present invention is directed to catheters adapted for passagethrough the accessory channel of an endoscope into a duct or passagewaywithin the gastrointestinal system of the body. Although not limited inits applicability and scope, the invention has particular applicabilityto procedures which involve the advancement of the catheter to positionswithin the biliary tract and especially to the practice of EndoscopicRetrograde Cholangiopancreatography.

BACKGROUND OF THE INVENTION

A number of procedures have evolved in recent years using instrumentsintended to be inserted through an endoscope in various positions withinthe gastrointestinal system for the purpose of diagnosis and fortherapeutic procedures, including the insertion of stents, devices forthe extraction of stones from the biliary duct, the removal of polypsand the extraction of tissue for biopsy purposes.

One diagnostic technique which has come into use is EndoscopicRetrograde Cholangiopancreatography (ERCP) which is described incopending application Ser. No. 07/880,842, filed May 11, 1992. The ERCPtechnique is an endoscopic technique which involves the placement of aside-viewing instrument within the descending duodenum. The procedureeliminates the need for invasive surgical procedures for identifyingbiliary stones and other obstructions of the biliary and pancreaticducts. As background of the invention, the ERCP technique exemplifiedthe problems and difficulties which the present invention addresses.

Utilizing this technique, the Papilla of Vater and common biliary ductare cannulated, contrast medium injected and pancreatic ducts and thehepatobiliary tree visualized radiographically or examined with aduodeno fiberscope. Skilled medical practitioners can visualizeapproximately 90-95% of the biliary and pancreatic ducts using thistechnique.

ERCP is typically performed on an X-ray table. During the procedure, thepatient's oropharynx is anesthetized with topical lidocaine, and thepatient is sedated intravenously with diazepam. Atropine and glucagonare given intravenously to relax the duodenal muscles.

The ERCP procedure has heretofore typically been performed by theendoscopic introduction of a single lumen catheter into the pancreaticand common biliary ducts of a patient. Such ERCP catheters havetypically been constructed from Teflon®. At times, a spring wire guidemay be placed in the lumen of the catheter to assist in cannulation ofthe ducts. A stylet, used to stiffen the catheter, must first be removedprior to spring wire guide insertion. The introduction of the springwire guide eliminates the ability to inject contrast medium or makes ithighly cumbersome.

To summarize the procedure, an ERCP catheter is initially insertedthrough the endoscope and into the biliary or pancreatic ducts. Ifdifficulty is encountered or if the operator so desires, a spring wireguide is threaded into the catheter to assist in the cannulation. Afterthe catheter is inserted into the duct and threaded over the spring wireguide, the spring wire guide is removed. A radio-opaque contrast mediumis then injected through the single lumen of the catheter in order toidentify obstructions such as bile stones. Once located and identified,such stones can then be eliminated or destroyed by methods such asmechanical lithotripsy utilizing a device such as an Olympus BML-10/20Mechanical Lithotriptor.

This method of performing ERCP has several disadvantages. Most notably,it relies upon the use of a single lumen catheter which is threaded overthe spring wire guide or pushed by a stylet and then, upon the removalof the stylet or spring wire guide is then used for infusingradio-opaque contrast medium or dye into the biliary and pancreaticducts. Unfortunately, the process of withdrawing the stylet or springwire guide in order to clear the single lumen for contrast medium or dyeinfusion frequently repositions the catheter. Thus, when theradio-opaque or contrast medium is injected into the catheter, thecatheter is often improperly positioned for proper fluoroscopy or X-rayvisualization. Moreover, this method presents the further problem ofhaving to repeatedly remove the stylet or an approximately six foot longspring wire guide, maintain its cleanliness and then reinsert it intothe catheter. In addition, the dye is sticky and reintroduction of theguide wire is made difficult due to the frictional resistance offered byit. Finally, single lumen catheters frequently experience the problem ofback-flow in which the radio-opaque dye is squirted back out the sideport of the catheter and onto the administering medical professional.

The above problems often result in the need to repeat the procedure anda time consuming exercise of trial and error. Multiple attempts atproperly positioning the catheter and spring wire guide are oftennecessary. Increased amounts of tracer dye associated with multipleinjections increase the risk of pancreatitis. Because the ERCP procedureis performed under sedation, the additional time required for propercatheter positioning tends to increase the risk to the patient.Furthermore, because of the considerable expense of maintaining aprocedure room, the use of single lumen ERCP catheters can addconsiderably to the expense of the procedure. Accordingly, practice ofERCP procedures has heretofore been limited to only the most skilledendoscopists.

SUMMARY AND OBJECTS OF THE INVENTION

The invention has particular applicability in the performing of ERCPprocedures, other diagnostic and surgical procedures performed withinthe biliary system, as well as other parts of the gastrointestinalsystem in general, by the use in such procedures of catheters having atleast two lumens, and preferably three or four lumens. The multi-lumencatheter assemblies of the invention are specially designed to beinserted into a duct or body passage through the accessory channel of anendoscopic instrument. A catheter assembly for use in carrying out theinvention comprises, in its broadest aspects, a catheter body ofsubstantially cylindrical shape and substantially uniform diameterhaving a plurality of independent lumens extending lengthwise thereof.At least two lumens exit at the distal tip of the catheter body witheach exit port facing generally distally along the passage beingexplored axially and forwardly. The catheters of the present inventionare sized to be passed through the accessory port of a conventionalendoscopic instrument. The catheters have a combined length sufficientto extend the length of the standard accessory channel and into the moreremote portions of the duct or passage and further have a proximalsection extending proximally of the endoscope channel for a sufficientdistance to allow for manipulation of the catheter by the user into themost extreme position. In the exemplary case of the biliary system, theinvention allows for substantially complete exploration andvisualization without the need to remove the spring wire guide.Follow-up procedures, such as stent placement, tissue sampling, use of apapillotome/sphincterotome or the like are accomplished through a lumenof the catheter already placed and may be accompanied by periodic dyeinjection and visualization without removal of the catheter. For certainof these procedures, the wire guide is preferably left in place, as willbe noted in the explanation which follows. A further advantageousembodiment of the invention involves a multi-lumen catheter with areduced diameter distal tip portion on which a dilatation balloon issecured. In a related embodiment, a reduced diameter distal end portionserves as a platform for a stent.

The use of multi-lumen catheters for procedures such as described aboveoffers many advantages over the prior art practice of using single-lumencatheters. As noted above, one important advantage is the facility forinjection of contrast medium so as to attain complete visualization of asystem of passages, such as the biliary tract, without the need toremove the spring wire guide. When one recognizes that a catheter foruse in ERCP procedures must be approximately 200 cm in length and thespring wire guide must be an additional 200 cm or so in length, the veryact of removal of the spring wire guide to allow for injection ofcontrast medium through a single-lumen catheter can be seen to be bothawkward and time consuming. Since the spring wire guide is needed againfor repositioning the catheter, its extreme length and resilient naturemakes it very difficult to avoid loss of sterility when it istemporarily removed from the catheter. Furthermore, when the spring wireguide is reinserted after injection of the contrast medium through thesingle lumen, it has been found that because the contrast medium tendsto be sticky, the resistance offered within the lumen impedesreintroduction. This condition is aggravated due to the relatively smalldiameter and the length of the lumen through which the spring wire guidemust be passed. Since the catheters can be properly placed much moreeasily with less trial and error, the provision of separate lumens fordye injection and guide wire placement has been found to dramaticallyreduce the use of tracer dye. In addition, the provision of a separatelumen for guide wire placement eliminates the risk that air will enterthe biliary tract as may occur when a single lumen is used for dye andguide wire. Still further, it is highly desirable to have further lumenswithin the catheter to allow for other procedures, such as theintroduction and removal of stents, the use of instruments, such aspapillotomes/sphinctertomes, biopsy cutters, stone extractors, forceps,knives and the like. Accordingly, it is an important objective of theinvention to provide a multi-lumen catheter of small enough diameter topass through the accessory channel of the endoscopic instrument havingthe following characteristics: to provide for additional lumens sized topermit the aforementioned procedures within the limited cross-sectionavailable; to retain the requisite flexibility so as to facilitatepassage to a final position within an extended tortuous passageway; andto maintain the patency of the lumens without bunching up or kinking asthe catheter is advanced over the spring wire guide and into a finalposition.

One aspect of the invention is the provision of a catheter constructedfrom a blend of resins producing a catheter body having peak stress ofat least 8000 psi and a torqueability of at least 0.3 inch ounce at bodytemperature, wherein torqueability is measured as resistance to twistingthrough 360° with one end of the catheter fixed. An important feature ofthe present invention involves the treatment of at least the distal endsection of the catheter with a hydrophilic coating. The hydrophiliccoating of the present invention provides a highly lubricated surfacewhich is activated by the presence of moisture. In the case of a biliarycatheter, the biliary fluids activate the coating as it enters thebiliary passage of the patient. The hydrophilic coating serves thefurther function of softening the catheter body so as to increase itssuppleness and kink resistance and lubricity. Further, the softeneddistal portion is less traumatic to the tissue within the body passage.In a preferred embodiment, the lubricous hydrophilic coating is confinedto that portion of the catheter liable to be inserted within theendoscope and the body passage. This facilitates initial passage of thecatheter to the desired position within the passageway, since thecatheter remains in a firmer state until it contacts the body fluid.Since the coating is quite slippery, its absence from the proximal endof the catheter allows the medical professional to retain a firm grip onthe catheter as it is manipulated to the desired position. The lubricoushydrophilic coating may optionally also be applied within the springwire guide lumen and other lumens provided for the insertion ofinstruments.

Preferably, catheters formed according to the invention are extruded,utilizing a blend of polymers comprised of nylon, especially nylon 11,and an ester linked polyether-polyamide copolymer (PEBA). In the case ofbiliary catheters, catheters having two or more lumens, one of which isof sufficient diameter to allow passage of a guide wire and to allowpassage of another device and the other for a dye or other injectablefluid and having an external diameter of between about 1.8 mm and about3.8 mm can be formed by an extrusion process. These catheters, whencoated with the lubricous hydrophilic coatings of the type hereinreferred, are extremely supple and offer a kink resistance notobtainable with prior art catheters formed of Teflon®. When formed fromthe resin blends of the present invention, the catheter material doesnot exhibit the tendency to bunch up on the wire guide as the catheteris pushed through the passageway. The catheters have good"torqueability", that is to say, the tip follows the proximal endwithout undue twisting when the medical professional rotates thecatheter during placement.

Preferably, the catheter has a central section substantially equivalentin length to the length of the accessory channel of a standard videoduodenoscope, a distal section substantially equal in length to theportion of the body passage to be negotiated and a proximal section of alength sufficient to allow for manual manipulation when the distalsection is in an extreme position within the body passage. At least thedistal section but not the proximal section is coated with a hydrophiliccoating which provides lubricity within the passage.

By providing exit ports in the distal tip of the catheter and orientingthe ports in a generally axial direction, so that devices or injectablefluids exit distally of the catheter, procedures which involve theadvancement of the catheter over the spring wire guide, use of apapillotome or other instrument and injection of contrast medium atsuccessive locations along a relatively confined duct or passageway,such as the biliary duct, are facilitated. By use of at least two lumenshaving ports facing generally forwardly in the direction of movement ofthe catheter, removal of the wire guide from the catheter during otherprocedures can be avoided. Direct visualization devices and otherinstruments can be passed through one lumen while the spring wire guideremains in place in a second lumen for ongoing repositioning of thecatheter as is desired by the user. Catheters according to the inventionmay be provided with a dilatation balloon or a supporting surface on thedistal tip portion for support of a stent. Desirably, additional lumensare reserved for the injection of a tracer dye and aspiration of biliaryfluid.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overall view of a dual-lumen biliary catheter of thepresent invention;

FIG. 2 is a partially broken away, partial section view on an enlargedscale as compared to FIG. 1 of a dual-lumen biliary catheter of thepresent invention;

FIG. 3 is a side view, partly in section, of a dual-lumen biliarycatheter body formed according to the present invention illustrating thedistal tip illustrating the contrast stripes at the distal end of thecatheter;

FIG. 3A is a section view illustrating the dual lumens of the biliarycatheter of FIGS. 1-3 taken along line 3A--3A of FIG. 3;

FIG. 3B is a fragmentary side view of a dual-lumen catheter having aballoon at the distal tip and having the cross-sectional figuration ofFIG. 3A;

FIG. 4 illustrates a biliary catheter of the present invention throughan endoscope accessory channel at the point of introduction into thecommon biliary duct;

FIG. 5 is an enlarged detailed view of a catheter of the presentinvention illustrating its exit from the distal tip of the accessorychannel of the endoscope;

FIG. 6 is a side elevational view of an alternative distal tipconfiguration for the biliary catheter of the present invention;

FIG. 7 illustrates the catheter including guide wire feed apparatusutilized with the present invention;

FIGS. 8 and 8A illustrate views illustrating the unlocked and lockedposition of a guide wire locking mechanism used with the invention;

FIGS. 9A and 9B are side and top views, respectively, of a catheter ofthe invention having a beveled tip and digitized markings;

FIG. 10 is an end view of the catheter of FIGS. 9A and 9B;

FIGS. 11 and 12 are side and end views of the distal tip section of atriple-lumen polypectomy catheter formed according to the invention;

FIG. 12A is a cross-sectional view of a modified form of the polypectomycatheter illustrated in FIGS. 11 and 12;

FIGS. 13A and 13B illustrate the distal and proximal end sections,respectively, of a triple-lumen dilatation balloon catheter formedaccording to the invention;

FIG. 14 is a detail view on an enlarged scale, in section, of a portionof the catheter of FIGS. 13A and 13B;

FIG. 15 is a sectional view on an enlarged scale taken on line 15--15 ofFIG. 13A;

FIG. 16 is a sectional view on an enlarged scale taken on line 16--16 ofFIG. 13A;

FIGS. 17A and 17B illustrate the distal and proximal end sections of amulti-lumen catheter in placing a stent;

FIG. 18 is a sectional view enlarged with respect to FIGS. 17A and 17Billustrating the distal portion of the catheter with the stent inposition;

FIG. 19 is a cross-sectional view of a four-lumen catheter used for thepurposes of cannulating the common bile duct and the pancreatic duct;

FIG. 20 is a cross-sectional view of a triple-lumen catheter in which apapillotome is accommodated for the purpose of tissue cutting as an aidto catheter insertion;

FIG. 21 illustrates a modified form of dual-lumen catheter useful forstone removal;

FIG. 22 is a cross-sectional view of a triple-lumen catheter used forstone visualization and removal;

FIG. 23 is a cross-sectional view of an alternative embodiment of acatheter used for the purposes explained with respect to FIGS. 13A-16;and

FIG. 24 is a cross-sectional view of a catheter used for stent placementand removal.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Preferred embodiments of the improved catheters of the present inventionare described with reference to FIGS. 1-18, wherein unless otherwiseindicated, the same numbers are utilized to denote the same orequivalent parts. For the purpose of description, the present inventionwill be described in the context of its use in the cannulation andvisualizing of the common biliary duct of a patient pursuant to an ERCPprocedure. It is to be recognized that the present invention isapplicable to all ERCP procedures involving the cannulation andradiological visualization of the common biliary, pancreatic, commonhepatic and cystic ducts and to related procedures, including thoseinvolving cholecystectomy, papillotomy, polypectomy and sphincterotomy,as well as biopsies, placement of stents and the use of cytologybrushes.

Referring generally to FIGS. 1-3, a dual-lumen biliary catheter 10,constructed in accordance with the present invention, is illustrated. InFIG. 1, is showing a preferred embodiment of a dual-lumen catheter, thecatheter of the present invention comprises a cannula or tubularcatheter body 12 having a proximal end 12a for connection to a branchingconnector 14 and a distal end 12b for insertion into the biliary duct ofa patient. Tubular body 12 has a substantially circular cross-sectionalshape and a uniform outer diameter. Two independent lumens extendlengthwise thereof and exit through separate ports at the distal tip.Preferably, the catheter is provided with a tip having a relativelysharp bevel, although unbevelled blunt tips and conically formed tipsmay sometimes be employed. For reasons which will be understood from thefollowing explanation, the two lumen ports within the tip are orientedso that they face forwardly and substantially along the path of advanceof the catheter.

Tubular body 12, in a preferred embodiment of a biliary catheter, has alength of approximately 200 cm. This length is sufficient to allow thecatheter 10 to be inserted endotracheally into a patient via anendoscope and to reach within the biliary and pancreatic ducts locatedadjacent the patient's duodenum via an attached fiberscope during anERCP procedure.

The proximal end 12a of catheter body 12 attaches to branching means 14which couples the body 12 to spring wire guide feeding means 16 andcontrast medium infusion means 18. In a preferred embodiment as shown inFIGS. 1, 2 and 4, branching means 14 comprises a polymeric branchingconnector 15 which joins the spring wire guide feeding means 16 andcontrast medium infusion means 18. The branching connector 15 mayinclude a connector 19 having an affixed apertured wing 20.

Referring to FIGS. 1 and 2, the spring wire guide feeding means 16, in apreferred embodiment, comprises a port having an eighteen gauge luerlock hub 17 which is affixed to the branching connector means 14. Thespring wire guide feeding means 16 is utilized to feed a spring wireguide 24 into and out of one lumen of the catheter 10. A spring wireguide utilized in the embodiment of FIGS. 1-3A preferably has a diameterof about 0.035 inches. The use of a spring wire guide having thisdiameter permits the spring wire guide to be used for placing anindwelling stent, to be discussed below.

The spring wire guide 24 may optionally be coated with Teflon® in orderto add to its lubricity. The spring wire guide of the present inventionis preferably fed and withdrawn with the assistance of an auxiliaryapparatus, such as the spring wire guide feed apparatus disclosed inU.S. Ser. No. 07/608,234 entitled "Hand Held Device For Feeding A SpringWire Guide", filed Nov. 2, 1990, and now U.S. Pat. No. 5,125,906assigned to Arrow International Investment Corp., assignee of thepresent invention, and which is incorporated herein by reference. Anoverall view of such a device 27 is illustrated in FIG. 7. Device 27includes an elongated coiled conduit 27a within which the spring wireguide 24 resides when not in use and a feed device 27b which allows forhand feed of the wire. As shown in FIGS. 7, 8 and 8A, the spring wireguide feed device 27 is preferably affixed to the inlet hub of a wireclamping means, such as snap lock adapter 29 for locking the position ofthe wire. Snap lock adapter 29 basically comprises a knob 29a which camsa tubular portion 29b radially inwardly to grip the spring wire guideupon relative movement of the parts toward one another. FIGS. 8 and 8Aillustrate the respective unlocked and locked positions of the adapter.

Referring to FIGS. 1 and 2, the contrast medium infusion means 18, in apreferred embodiment, preferably comprises a polymeric tube 26 whichincludes a twenty-gauge connector 28 secured to tube 26 at one end. Theconnector 28 has a threaded outer surface 30 onto which a cap or stopper(not shown) may be affixed. The interior 28a of the connector 28 istypically luer shaped and is designed to be coupled to a syringecontaining radio-opaque contrast medium or dye. The contrast medium ordye is injected down tube 26 and into a contrast medium lumen 34 of thecatheter, as discussed below.

Referring to FIGS. 2 and 3, the distal end 12b of the tube 12 is shownin detail. The distal end of the catheter includes a bevelled tipportion 12b and means 25 extending proximally of the tip portion forrendering sections of contrasting the outer distal surface of catheterradio-opaque. Contrast means 25 facilitates the visual identification ofthe distal end of catheter 10 by the endoscope. In a preferredembodiment, means 25 comprises a plurality of non-toxic ink stripes 25a,formed using an ink such as is sold under the specification 2920 by GemGravure of West Hanover, Mass. It is to be appreciated that contraststripes 25a comprising other materials may be utilized in the catheterof the present invention. Moreover, it is to be appreciated by thoseskilled in the art that the entire catheter 10, or portions thereof, maybe or applied with any acceptable contrast medium. As shown in FIGS. 9Aand 9B, the tip 12b of the catheter may be calibrated as at 25a atpredetermined intervals, such as 5 mm.

As further illustrated in FIGS. 1-3, 9A and 9B, the preferred cathetertip 12b is beveled to facilitate ease of insertion and passage. Arelatively steep bevel has been found to be an optimal configuration inthat it is relatively easy and non-traumatic to position the catheterand affords reasonable resistance to bending and buckling.

Referring to FIGS. 3 and 3A, the lumens 32, 34 of a preferred form ofdual-lumen catheter 10 of the present invention are shown so as todetail their cross-sectional shape. The catheter 10 includes spring wireguide lumen means 32 and contrast medium lumen means 34. The lumen means32, 34 extend along the entire length of the catheter body, alongparallel paths between the proximal end 12a and distal end 12b.Referring to FIGS. 9A, 9B and 10, distal end 12b is shown bevelled withthe contrast medium lumen means 34 terminating just distally of thespring wire guide lumen means 32. In all embodiments, lumens 32 and 34exit through ports in the distal tip which are oriented so that theyface generally lengthwise or axially of the catheter. As illustrated inFIGS. 9A and 10, the contrast lumen port 34 is located in theperpendicular portion of the tip, whereas the major portion of the guidewire lumen port is in the beveled position. In biliary catheters, it ispreferred that the port for lumen 32 be within about one-quarter inch ofthe distal tip. Preferably, the dye lumen is at the tip so as toeliminate interference with dye flow by the side walls of a narrowpassageway and/or by the guide wire.

As best shown in FIGS. 3A and 10, spring wire guide lumen means 32 iscircular in cross-section and has a diameter of about 0.05 mm to allowpassage of a 0.035 mm wire guide, a stent or other device of similarsize. The top of spring wire guide lumen 32 is defined by an arcuateseptum 32a which defines the interior sidewall of the contrast mediumlumen 34. In a preferred dual-lumen embodiment, contrast medium lumen 34is crescent shaped. While certain preferred embodiments of the presentinvention are described in the context of a biliary catheter having duallumens, the present invention such catheters having more than twolumens. Further, while the present invention is described with respectto a contrast medium lumen 34 having a crescent shape as a means ofmaximizing lumen size within a relatively small diameter catheter body,certain of the objectives of the invention may be achieved when thecontrast medium lumen assumes one of a plurality of other geometricshapes.

Catheters of the present invention may be constructed from extrudiblepolymers. Preferable proportions are about 18-22 wt. % barium sulfate,about 40 wt. % to about 60 wt % nylon 11 and about 20 wt. % to about 40wt. % PEBA. A blend of 60 wt. % nylon 11, 20 wt. % PEBA and 20 wt. %barium sulfate is especially preferred. Nylon 11 sold under thetrademark BESVOA and PEBA sold under the trademark Pebax are availablefrom Elf Atochem, Philadelphia, Pa. The barium sulphate allows for easyvisualization and catheter location under fluoroscopy and has beenobserved to increase stiffness. This blend is readily extruded intomulti-lumen catheters having an o.d. ranging from 3.8 mm down to about1.8 mm. Catheters formed from this blend have the requisite balance oftorqueability, resistance to bunching and stretching and goodflexibility.

A further important feature of the present invention is the addition ofa hydrophilic coating on the outer surface of the catheter 10 andoptionally within the spring wire guide lumen 32. The hydrophiliccoating, when applied to the catheter, imparts suppleness and kinkresistance to the catheter. The hydrophilic coating further apparentlyreduces the hardness of the polyurethane or nylon. The hydrophiliccoating of the preferred embodiment comprises Methylene Chloride (MeCl),Polyethylene Oxide (PEO) and Tyrite 7617 Adhesive.

The hydrophilic coating is preferably applied to the catheter pursuantto the following process. Initially, 1400 ml of MeCl is poured into acontainer which is placed on stirrer plate. A stirring magnet is thendropped into the beaker, and the stirring plate is activated. Stirringis adjusted until a vortex forms. Next, 14.91 g.±0.02 g. of PEO areslowly added to the stirring solution. The solution is stirredcontinuously for about 10 minutes in order to break up any lumps of PEO.Using a syringe, about 15.75 ml Tyrite 7617 adhesive is added to thestirring solution which is stirred for an additional five minutes. Thestirred solution is then poured into a treatment tank.

The catheter 10, with its end sealed off, is then dipped into the tankuntil the portion to be coated is immersed. The catheter 10 is left inthe tank for about 1 second, quickly retrieved and the excess solutionallowed to drip into the tank. The catheter is then air dried for about8 hours.

The catheter 10 with hydrophilic coating provides a highly lubricatedsurface which is activated by the biliary fluids of the patient. Thehydrophilic coating may also be activated by the gastric fluids whichenter the endoscope. The hydrophilic coating reduces the durometer ofthe catheter and imparts kink resistance and suppleness to the catheter.The coating has been found to yield a lower coefficient of friction thanthat of comparable Teflon® catheters. While the present invention isbeing described in the context of a preferred hydrophilic coating, it isto be appreciated that other hydrophilic coatings may be utilized in thepresent invention. Examples of such hydrophilic coatings are found anddescribed in U.S. Pat. No. 4,943,460 entitled "Process for CoatingPolymer Surfaces and Coated Products Produced Using Such Process."Another hydrophilic coating is Hydromer® "Slippery When Wet" coatingmanufactured by Hydromer, Inc. of Whitehouse, N.J. Preferably, theslippery coating is not applied to the proximal end section of thecatheter so as to facilitate manual manipulation thereof during catheterplacement.

The operation and use of the biliary catheter 10 as so far described isnow explained with reference to FIGS. 1 though 6. Initially, the patientis sedated or, in rare situations, placed under general anesthesia.Using the spring wire guide advancer, the wire guide 24 is insertedthrough an endoscope and exits through the side of an attachedfiberscope 36, the end of which is shown in FIG. 5 is situated in thepatient's duodenum 38. The catheter 10 is then threaded over the springwire guide 24 via spring wire guide lumen 32 and fed through theaccessory channel 36 and both catheter and wire guide are advanced intothe common bile duct 40.

Next, a pre-filled syringe of radio-opaque dye or contrast medium isattached to a connector 28. A sufficient amount of dye to fill thecatheter is then injected into tube 26. A clamp or adhesive tape may beused to lock the relative positions of the catheter and spring wireguide. An example of a clamp which achieves the function is a clamp ofthe Series 340 clamps marketed by Halkey Medical of St. Petersburg, Fla.Contrast medium is then injected into the contrast medium lumen 34 whichexits at distal end 12b and into the common biliary duct 40, therebypermitting X-ray or fluoroscopic visualization of the duct 40. Digitizedmarkings 25a facilitate precise adjustment of the catheter. If theposition of the catheter needs to be adjusted, the spring wire guide 24is advanced and the catheter 10 advanced accordingly. The catheter canbe rapidly adjusted and contrast medium or dye can be repeatedly infusedwithout the need for repeated insertion and removal of the spring wireguide 24.

The present invention-thus provides for probing with the spring wireguide 24 via lumen 32 and the injection of contrast medium or dye viacontrast medium lumen 34, further probing and further injection of dyeuntil a proper catheter position is achieved. The present inventioneliminates the time consuming step of removing the spring wire guide 24prior to each change in catheter position and contrast medium infusion.The use of the catheter of the present invention can save over 20minutes of time during a typical ERCP procedure. In addition, a laserfiber for biliary lithotripsy can be placed through one lumen withongoing injection of contrast medium or fluid in the second lumen.Further, selective cannulation of the right and left hepatic ducts,cystic ducts or pancreas becomes more directed, safe and efficient.

A particular feature of the present invention is its adaptability foruse in placing a stent around a biliary calculus 42 or cystic orpancreatic obstruction. In approximately 5% of all ERCP cannulations,surgery is mandated. However, surgery is often not always possible atthe time of the ERCP procedure. In such situations, a stent is typicallyplaced within the common biliary or pancreatic duct around the calculus.

As used in one procedure for stent placement, the catheter 10 isutilized in association with a spring wire guide 24 having a lengthgreater than twice the length of the catheter 10, or over 400 cm inlength. The spring wire guide may be threaded with the catheter into theendoscope, as described above. The spring wire guide utilized in thisembodiment should preferably have a diameter of about 0.035 inches. Thestent is tubular with a longitudinally extending slit which permits itto be fitted over the wire guide.

The spring wire guide is advanced to a desired position within thecommon biliary duct and the catheter then advanced relative to the wireinto a final position. Contrast medium or dye is infused, and thecalculus 42 is located, as shown in FIG. 6. The catheter 10 is thenremoved from the endoscope.

Because the spring wire 24 guide has a length greater than twice that ofthe catheter 10, the catheter 10 can be completely removed from theendoscope over the spring wire guide 24 without the need for withdrawingthe spring wire guide. After the catheter 10 is removed, a stent may beplaced forward of the catheter over the spring wire guide. The catheteris utilized to push the stent into the endoscope, over the spring wireguide, into the common biliary duct and around the biliary calculus 42.When the stent is in position, the spring wire guide 24 is then removedalong with the catheter.

A catheter, as shown in FIGS. 3 and 3A, having a balloon adjacent itsdistal tip, as shown in FIG. 3B, may be used with a wire having aniridium charge placed in its distal tip so as to dispose iridium fortreatment in the biliary tract. In this treatment application, the wireemployed is preferably a 0.035 inch wire and is passed through a nasalpassage using an endoscope. After the wire is positioned within thebiliary tract, the endoscope is removed and the catheter is advancedover the guide wire using lumen 32 as the guide wire lumen adapted to bepassed through round lumen 32 having a diameter of 0.040 inches. Lumen34 serves as the inflation lumen and exits in a radial port forinflation of the balloon. The overall diameter of the catheter is 2.8mm. Once the iridium, which may be fitted into the tip of the catheterat 35, is properly placed, the balloon is inflated through lumen 34 tomaintain both catheter and iridium in place. Although the catheter maybe deployed orally as in other procedures due to the length of theiridium treatment, the catheter is preferably inserted through a nasalpassage.

Catheters having the cross-section of FIG. 3 are also useful for tissuesampling with a brush. In this application, lumen 32 preferably has adiameter of about 0.040 inches. Lumen 34 is utilized for a salinesolution for the purpose of cleansing the tissue to be sampled prior toobtaining the sample with the brush.

A triple-lumen catheter used in the practice of polypectomy is disclosedin FIGS. 11 and 12. The catheter illustrated in FIGS. 11 and 12 has afirst lumen 48 dimensioned to pass a polypectomy snare, a second lumen49 through which an injection medium will be passed and a retrievallumen 50 for passage of a basket or other retrieval device. Lumen 49 orlumen 50 may be used to pass a flexible plastic or stainless steelneedle for injecting a polyp once it is visualized to further assist thephysician in excising the polyp with a snare. As indicated in FIG. 11,where a snare is illustrated projecting from the lumen port 48, thesnare is a device which uses radio frequency energy to cauterize theroot of the polyp and the energy so used exists through a plate in whichthe patient is seated. Once the polyp is incised, a net, basket or otherretrieval device of known construction is passed through lumen 49 forgrasping and retrieval of the polyp through the lumen. If a large polypis to be removed, the catheter itself is removed at this point. Thecatheter of FIGS. 11 and 12 has an external diameter of 2.5 mm. Thesnare lumen has a diameter of 0.5 mm, whereas the lumens 49 and 50 havediameters of 0.4 mm. Lumen 48 exits through the bevelled portion of thedistal tip, whereas lumens 49 and 50 exit through the portion disposedperpendicular to the long axis of the catheter.

For certain purposes, the dual-lumen catheter configuration of FIG. 12Amay be satisfactory for the practice of polypectomy. As utilized, thecatheter configuration of FIG. 12A is provided with a lumen 48a of about0.050 inches in diameter for passage of the snare and a lumen 49a ofabout 0.040 inches in diameter for the injection needle device.Retrieval is effected by withdrawal of the catheter with the embodimentof FIG. 12A. The catheter illustrated in FIG. 12A preferably has anoutside diameter of about 2.8 mm.

Still another embodiment of the invention, as illustrated in FIGS.13A-16, is a triple-lumen catheter having a dilatation balloon 52 whichmay be used, for example, to facilitate removal of gall stones by thedilation of a restricted portion of the biliary tract. The catheter ofFIGS. 13A-16 has a main body portion 53 of a first uniform outerdiameter and a distal tip portion 54 of a smaller uniform outerdiameter. Preferably, the distal tip has a bevelled configurationsimilar to the tip of the embodiment of FIGS. 1-3.

The catheter of FIGS. 13A-16 has a first lumen 55 which extendslengthwise thereof from a connector 56 to an exit port at the distal tipin the manner illustrated in FIG. 10. Lumen 55 is preferably sized topermit the passage of a 0.035 inch guide wire. A second crescent shapedlumen 57, as illustrated in FIGS. 15 and 16, also exits in a port at thedistal tip and provides for the injection of tracer dye. The catheter isalso provided with a third lumen 58 which exits in a shoulder 59separating the larger diameter main body portion 53 from the smallerdiameter tip portion 54. Lumen 58 is provided for the delivery of aninflation medium for inflating the balloon 52. The inflation mediumemployed is desirably an incompressible fluid and is typically a salinesolution. The fluid may include a tracer dye to permit visualization ofthe balloon by fluoroscopy. The catheter of FIGS. 13A-16 has a maximumdiameter of 2.8 mm to allow for passage through the accessory channel ofan endoscope and a diameter of approximately 1.8 mm in the distal tipportion. The use of a smaller diameter distal tip portion facilitatespassage into more remote portions of the biliary tract and also providesroom for packing the uninflated balloon so that it does not projectappreciably beyond the surface of the large diameter catheter bodyportion.

In use, the catheter of FIGS. 13A-16 is advanced utilizing the wireguide, as described above, until the desired position is reached,utilizing a tracer dye and fluoroscopy to assist in the guidance of thecatheter to the desired location. Balloon 52 is inflated when the eventa stricture in the biliary duct is encountered. Once the duct isdilated, stones encountered may, in many cases, dislodge and begin toremove themselves naturally, but if need be, a stent may be inserted tomaintain patency of the duct to encourage the passage of the stone orthe guide wire may be removed and an extractor device may be employedutilizing lumen 55.

FIGS. 17A-18 illustrate a catheter having utility for the placement of astent in the biliary tract. The catheter of FIGS. 17A-18 is similar instructure to the catheter of FIGS. 13A-16 in that it has a main bodyportion 60 of a first diameter and a distal tip portion 61 of a secondsimilar diameter on which a stent 62 is supported. In the illustrativeembodiment, the distal portion 61 has an outer diameter of 1.8 mm whichis suitable for supporting a 10 French tubular stent formed of abiologically inert material, such as polyurethane. As seen in FIG. 18,when stent 62 is placed on the distal tip portion, its proximal endsurface bears against a shoulder formed between the larger diameter bodyportion 60 and the reduced diameter distal end portion 61. In theillustrative embodiment, main body portion 60 has an outer diameter of2.8 mm for passage through a 3.2 mm endoscope accessory channel. Theouter diameter of stent 62 is approximately 3 mm. The catheter of FIGS.17A-18 is provided with two independent and continuous lumens 55 and 57preferably having the configurations of the lumens in FIG. 16. Lumen 55is dimensioned to accept a 0.035 wire guide which exits at the distaltip. The crescent shaped lumen 57 provides for the injection of tracerdye for use in visualization of the passage and location of thestricture where the stent is intended to be placed. In use, the catheteris advanced over the wire guide using the tracer dye to assist inplacing it. When the stricture is located and the stent properlypositioned, the catheter and guide wire are withdrawn leaving the stentin place. As is known in the art, stent 62 is provided with barbs 63which hold the stent in position as the catheter is withdrawn. The barbsare yieldable upon application of a predetermined force by a retrievaldevice when it is desired to remove the stent. An advantage of theembodiment of FIGS. 17A-18 is that the relatively small diameter distalportion relatively easily negotiates restricted portions of the duct.The procedure is facilitated by the existence of the guide wire withinthe catheter which provides a certain degree of stiffness to thecatheter and resistance to kinking.

Catheters having three or more lumens, as illustrated in FIGS. 11-16,allow for the performance of other procedures in conjunction with ERCPor the use of a lighting device while allowing the spring wire guide toremain in place. Triple-lumen catheters having outside diameters rangingfrom 3.8 mm down to about 1.8 mm may be extruded utilizing the resinblends described above with three lumens having inside diameters of 0.5mm with a minimal wall thickness of 0.005 inches. One such lumen willaccommodate an 0.018 mm spring wire guide, while the second lumen isreserved for infusion of contrast medium, and a third such lumen isreserved for additional instruments, such as a papillotome orsphincterotome, a snare, a basket and other accessories, such asforceps, stone extractor, biopsy cutters-or direct visualizationlighting devices. Additionally, a lumen may be provided which exitsradially at a location spaced adjacent the distal tip for inflation of adilation balloon used for dilating the tract for removing bile stones ora previously introduced stent. Catheters formed in accordance with theinvention are useful for the endoscopic examination and treatment ofother parts of the gastrointestinal system as well. Multi-lumencatheters can be provided with outer diameters of 3.8, 2.8 and 1.8 mmwhich allow for use with standard endoscopes having channels withinternal diameters of 4.2, 3.2 and 2.2 mm, respectively.

An important advantage of a catheter having three or more lumens is thatthe guide wire may be maintained within its lumen while performing aprocedure involving advancement of a device, such as a cytology brush,papillotome/sphinctertome or an optical visualizer, allowing a thirdlumen to be reserved for the injection of dye. The presence of the guidewire serves to prevent kinking and collapse of all lumens, thus allowingfor unimpeded advancement of the device employed, dye injection and/oraspiration of bile for laboratory analysis through a lumen notcontaminated with dye. The guide wire also facilitates switching fromone device to another. When using an optical device, a fourth lumen maybe advantageously reserved for injection of saline solution to clear thearea being visualized prior to use of the device.

Further specific embodiments and procedures of use for multi-lumencatheters formed according to the invention are described withparticular reference to the cross-sectional views of FIGS. 19-24.

FIG. 19 is a cross-section of a multi-lumen catheter utilized fordisposing two 0.035 inch guide wires simultaneously, one within thepancreatic duct and one through the cystic duct through lumens 70 and71, utilizing contrast medium injected through lumens 72 and 73. Oncethe guide wires are in place, the catheter of FIG. 19 is withdrawn andindividual catheters advanced over the selected guide wire forcatheterization of either the pancreatic or cystic duct. The catheter ofFIG. 19 preferably has an outer diameter of about 2.8 mm. The catheterof FIG. 19 is of advantage when an uncertainty exists as to the extentand location of patient stress.

FIG. 20 illustrates a cross-section of a catheter with which anelectrosurgical cutting instrument in the form of apapillotome/sphinctertome 74' is used for tissue cutting as an aid forcatheter insertion. In use of the catheter of FIG. 20, circular lumen 74is reserved for the papillotome/sphinctertome 74' which is preferablypermanently mounted the lumen. Placement of the catheter of FIG. 20involves use of additional lumen 75 for a guide wire and additionallumen 76 for contrast medium in the manner described above with respectto FIGS. 1-12. The catheter of FIG. 20 preferably has an outsidediameter of about 2.8 mm.

FIG. 21 is a cross-section of a catheter useful in procedures for stoneremoval. Lumen 78 (upper) is used for the passage alternatively of aguide wire or a fiber optic device for visualization of stones. Lumen 79is reserved for passage of a stone basket. Alternatively, the catheterof FIG. 21 may be equipped with a dilatation balloon adjacent its distaltip which is inflated with an incompressible medium. After placement ofthe distal tip, the balloon is inflated to dilate the duct to effectdislodgment of the stone. A catheter so constructed will have an outsidediameter of approximately 2.8 mm. At the option of the physician, theguide wire may be removed and replaced with the optical device forvisualization of the stone removed by the basket or by dislodgment withthe balloon.

An alternative use of a catheter having the configuration of FIG. 21includes use of a vacuum assist for stone removal by application of avacuum to one of the lumens while reserving the other either for a stoneretrieval basket or as the inflation lumen for the balloon. To maximizelumen size in this application, the catheter preferably has an outsidediameter of about 3.8 mm.

The cross-sectional view of FIG. 22 depicts an alternative form ofcatheter used for visualization and removal of gall stones. Asillustrated in FIG. 22, lumens 82, 83 are used for injection of contrastmedium and for a guide wire respectively. Lumen 84 is reserved for abasket for the removal of stones. Once the catheter is within thebiliary tract, the guide wire is removed from lumen 83 and replaced witha fiber optic visualization device to confirm that the stone, not a airbubble, is present. The basket is then manipulated through lumen 84 toretrieve the stone. The catheter of FIG. 22 has an outside diameter ofabout 2.8 mm.

FIG. 23 is an end view of triple-lumen catheter alternative to thatshown in FIG. 15 in which the inflation lumen, shown at 86, is anannular lumen. As in FIG. 15, the catheter in a preferred form isprovided with a circular lumen 87 for a 0.035 inch guide wire and acrescent-shaped lumen 88 for injection of contrast medium. The catheterof FIG. 23 preferably has a 2.8 mm outside diameter and is in otherrespects substantially the same as the embodiment illustrated in FIGS.13A-16.

FIG. 24 illustrates an end view of a modified version of the catheter ofFIGS. 17 and 18. According to FIG. 24, the catheter depicted has a guidewire lumen 90, a retrieval lumen 92 for a basket or snare and a dyelumen 94, all extending through the reduced diameter distal tip portion.Except for the inflation lumens, the lumens in FIGS. 19-24 extendcontinuously and independently and exit through axially facing ports.The catheter of FIG. 24 has a maximum outside diameter of about 3.8 mm.The reduced diameter distal portion has a diameter of about 2.8 mm whichallows for support of a 7 French stent 95 having its circumference flushwith the circumference of the remainder of the catheter. Once the stentis visualized, the snare is utilized to grasp its proximal end. Thestent is withdrawn by withdrawing the snare and, if necessary, thecatheter until the stent is within the large intestine where it may bereleased. Thereafter, the guide wire is used to locate the tip of thecatheter at the desired location with the biliary or cystic duct. Thecatheter is withdrawn with the stent remaining in place and the catheterthen removed further until it is within the intestine. The snare orbasket is then used to pick up the old stent and the endoscope andcatheter are then withdrawn from the body.

The present invention has been described with reference to the attachedFigures and described embodiments. It is to be appreciated that otherembodiments may fulfill the spirit and scope of the present inventionand that the true nature and scope of the present invention is to bedetermined with reference to the claims appended hereto.

What is claimed:
 1. A catheter assembly intended for advancement andmanipulation through the accessory channel of an endoscope into a bodypassage within the gastrointestinal system, said catheter comprising:asubstantially cylindrical, flexible catheter body having a uniform outerdiameter throughout its entire length; said catheter body having abeveled distal tip, a proximal end and at least first and secondindependent lumens extending lengthwise thereof, each said lumen havingan entry port at the proximal end of the catheter body and an exit portat the beveled distal tip,each said exit port facing axially of thecatheter body, and a third independent lumen extending lengthwisethereof, the third independent lumen having an exit port disposedproximally from the distal tip; and wherein said beveled distal tipcomprises a first, acutely angled, planar portion and second planarportion at a distal end of the first, said second planar portion beingperpendicularly disposed with respect to the long axis of the catheterbody, wherein one of said exit ports exits substantially through thefirst planar portion and the other of said lumens exits substantiallythrough the second planar portion.
 2. A catheter assembly according toclaim 1, wherein the exit port of the first independent lumen extendsthrough the first planar portion, and the exit port of the secondindependent lumen is in said second planar portion.
 3. A catheterassembly according to claim 2, wherein the exit port of the firstindependent lumen is spaced less than one-quarter inch from the secondplanar portion.
 4. A catheter assembly for advancement and manipulationthrough the accessory channel of an endoscope into a body passage withinthe gastrointestinal system, the catheter assembly comprising:anelongate catheter body having a proximal end and a distal end having adistal tip, the distal tip having an planar portion disposedperpendicular to the long axis of the catheter body, and a beveledplanar portion extending proximally from the planar portion; a firstelongate lumen extending from the proximal end to the distal end of thecatheter body, the first elongate lumen configured for receiving a guidewire and having an entry port at the proximal end of the catheter bodyand an exit port at the distal tip of the catheter body; a secondelongate lumen extending from the proximal end to a port in the distaltip of the catheter body, the second elongate lumen being configured forinjection of tracer dye out the port in the distal tip of the elongatecatheter body, such that tracer dye may be released from the distal tipof the elongate catheter body while a guide wire remains in the firstlumen; and a third elongate lumen extending from the proximal end of thecatheter body to a position adjacent the distal end of the catheterbody, the third lumen being configured for conducting a procedure otherthan guide wire placement or trace dye injection; and wherein catheterassembly further comprises an inflatable balloon disposed about thecatheter body proximally from the distal end, and wherein the catheterassembly includes a port disposed at the end of the third lumen andexiting into the balloon such that injection of a fluid into the thirdlumen inflates the balloon.
 5. A catheter assembly for advancement andmanipulation through the accessory channel of an endoscope into a bodypassage within the gastrointestinal system, the catheter assemblycomprising:an elongate catheter body having a proximal end and a distalend having a distal tip, the distal tip having an planar portiondisposed perpendicular to the long axis of the catheter body, and abeveled planar portion extending proximally from the planar portion; afirst elongate lumen extending from the proximal end to the distal endof the catheter body, the first elongate lumen configured for receivinga guide wire and having an entry port at the proximal end of thecatheter body and an exit port at the distal tip of the catheter body; asecond elongate lumen extending from the proxi catheter body, the secondelongate lumen being configured for injection of tracer dye out the portin the distal tip of the elongate catheter body, such that tracer dyemay be released from the distal tip of the elongate catheter body whilea guide wire remains in the first lumen; and a third elongate lumenextending from the proximal end of the catheter body to a positionadjacent the distal end of the catheter body, the third lumen beingconfigured for conducting a procedure other than guide wire placement ortrace dye injection; and wherein the third lumen extends to a positionadjacent the distal end of the catheter body, and wherein anelectrosurgical cutting element forming a sphinctertome/papillotome isdisposed in the third lumen.
 6. The catheter assembly of claim 5,wherein the sphinctertome/papillotome is permanently disposed in thethird lumen.
 7. A catheter assembly intended for advancement andmanipulation through the accessory channel of an endoscope into a bodypassage within the gastrointestinal system, said catheter assemblycomprising:a substantially cylindrical, flexible catheter body; saidcatheter body having a proximal end and a beveled distal tip and atleast two independent lumens extending lengthwise therebetween, eachsaid lumen having an entry port at the proximal end of the catheter bodyand an exit port at said distal tip, each said exit port facinggenerally axially of the catheter body; and wherein said catheter bodyfurther comprises a third independent lumen extending lengthwisethereof, an inflatable, radially expandable dilation balloon disposedadjacent said distal tip and an exit port for said third independentlumen establishing communication with the interior of the balloon.
 8. Acatheter assembly intended for advancement and manipulation through theaccessory channel of an endoscope into a body passage within thegastrointestinal system, said catheter assembly comprising:asubstantially cylindrical, flexible catheter body; said catheter bodyhaving a proximal end and a beveled distal tip and at least twoindependent lumens extending lengthwise therebetween, each said lumenhaving an entry port at the proximal end of the catheter body and anexit port at said distal tip, each said exit port facing generallyaxially of the catheter body; and wherein said beveled distal tipcomprises a first, acutely angled, planar portion and a second planarportion distally of the first, acutely angled planar portion and indisposed in contact with the first acutely angled planar portion, saidsecond planar portion being perpendicularly disposed with respect to thelong axis of the catheter body, wherein one of said exit ports exitssubstantially through the first planar portion and the other of saidlumens exits substantially through the second planar portion.
 9. Acatheter assembly according the claim 8, wherein the catheter bodyfurther comprises a third, accessory lumen extending lengthwise throughsaid catheter body, a third exit port located adjacent said distal tipfor said third, accessory lumen, said third, accessory lumen beingindependent of said other lumens and being sized for passage of a stoneextractor.
 10. A catheter assembly according the claim 8, wherein thecatheter body further comprises a third, accessory lumen extendinglengthwise through said catheter body to a third exit port locatedadjacent said distal tip for said accessory lumen, said accessory lumenbeing independent of said other lumens and being configured forreceiving a papillotome/sphinctertome.
 11. A catheter assembly accordingto claim 8, wherein the catheter body further comprises a third,accessory lumen extending lengthwise therethrough to a third exit portlocated adjacent said distal tip for said third, accessory lumen, saidthird, accessory lumen being independent of said other lumens and beingconfigured for passage of grasping forceps.
 12. A catheter assemblyaccording to claim 8, wherein the catheter body further comprises athird, accessory lumen extending lengthwise therethrough to a third exitport located adjacent said distal tip for said third, accessory lumen,said third, accessory lumen being independent of said other lumens andbeing configured for passage of a biopsy cutter.
 13. A catheter assemblyaccording to claim 8, wherein the catheter body further comprises athird, accessory lumen extending lengthwise therethrough to a third exitport located adjacent said distal tip in communication with said third,accessory lumen, said third, accessory lumen being independent of saidother lumens and being configured for passage of a cytology brush.
 14. Acatheter assembly according the claim 8, wherein the catheter bodyfurther comprises a third, accessory lumen extending lengthwise throughsaid catheter body to a position adjacent distal tip, said accessorylumen being independent of said other lumens and having anelectrosurgical cutting instrument forming a sphinctertome/papillotomedisposed therein.
 15. A catheter assembly according to claim 14, whereinthe sphinctertome/papillotome is permanently disposed in the third,accessory lumen.
 16. A catheter for advancement through the accessorychannel of an endoscope into a body passage within the gastrointestinalsystem, said catheter comprising:a substantially cylindrical, flexiblecatheter body having a substantially uniform outer diameter extendingthroughout its length; said catheter body having a proximal end and adistal tip and at least three independent lumens extending lengthwisethereof, each said lumen having an entry port at the proximal endthereof and at least a first lumen and a second lumen of said at leastthree independent lumens having axially facing exit ports disposed insaid distal tip, the first lumen being configured for receiving a wireguide and the second lumen being configured for injection of contrastfluid, and wherein a third lumen of the at least three lumens has anelectrosurgical instrument configured to form asphinctertome/papillotome disposed therein.
 17. A catheter according toclaim 16, wherein the sphinctertome/papillotome is permanently disposedwithin the third lumen.
 18. A catheter assembly for advancement andmanipulation through the accessory channel of an endoscope into a bodypassage within the gastrointestinal system, the catheter assemblycomprising:an elongate catheter body having a proximal end and a distalend; a first elongate lumen extending from the proximal end to thedistal end of the catheter body, the first elongate lumen configured forreceiving a guide wire and having an entry port at the proximal end ofthe catheter body and an exit port the distal end of the catheter body;a second elongate lumen extending from the proximal end to the distalend of the catheter body, the second elongate lumen being configured forinjection of tracer dye out the distal end of the elongate catheterbody, such that tracer dye may be released from the distal end of theelongate catheter body while a guide wire is disposed in the firstlumen; and a third elongate lumen extending from the proximal end of thecatheter body toward the distal end of the catheter body, the thirdlumen having an electrosurgical tissue cutting instrument disposedtherein.
 19. The catheter assembly of claim 18, wherein theelectrosurgical cutting instrument comprises apapillotome/sphinctertome.
 20. The catheter assembly of claim 19,wherein the papillotome/sphinctertome is permanently disposed in thethird lumen.
 21. The catheter assembly of claim 20, wherein the firstand second lumens extend continuously and exit through independentaxially facing ports in the distal tip of the catheter body.
 22. Thecatheter assembly of claim 20, wherein the catheter body issubstantially cylindrical and has a substantially uniform outer diameterextending throughout its length.
 23. A catheter assembly for advancementand manipulation through the accessory channel of an endoscope into abody passage, the catheter assembly comprising:an elongate catheter bodyhaving a proximal end and a distal end having a distal tip; first,second and third lumens formed within the catheter body, each of thefirst, second and third lumens extending from respective ports formedadjacent the proximal end and toward the distal end, the first andsecond lumens terminating in ports at the distal tip; andelectrosurgical tissue cutting means disposed in the third lumen forselectively cutting tissue, the tissue cutting means forming apapillotome/sphinctertome.